UK: A Bumper Crop Of SPC Rulings From The CJEU - Part 1: When Is An Ingredient "Active"?

1. Introduction

For those having an interest in Supplementary Protection
Certificates (SPCs), the months spanning November 2013 to February
2014 have been an important period. Thus is because the CJEU has
produced no fewer than six judgments and one Advocate-General's
opinion during that period.

All of the six rulings, as well as the opinion, are significant
in terms of their impact upon either the availability of SPC
protection or the duration of that protection.

This article, which focuses upon Article 1 of the SPC
legislation, is the first in a series of three that aims to explain
the various developments, as well as their likely practical
significance.

2. Background

2.1 General

SPCs are a unique form of intellectual property that are
intended to serve a similar purpose to patent term extensions
(PTEs) in other territories, such as the US and Japan.

SPCs provide a period of exclusivity that extends beyond normal
patent expiry. The exclusivity is awarded to the holders of patents
that protect certain types of regulated products that have been
officially approved for sale (i.e. that have received a Marketing
Authorisation (MA)). The regulated products that can benefit from
SPC protection are the active ingredients present in medicinal
products (either human or veterinary) or in so-called "plant
protection products" (i.e. agrochemicals and the like).

In common with PTEs, one of the stated objectives behind the
creation of SPCs was the encouragement of innovation through the
provision of a sufficient duration of post-marketing exclusivity.
However, SPCs achieve this objective in a very different way to
PTEs. Thus, although each SPC must be based upon a particular
patent, the exclusivity provided by SPCs does not extend the term
of that patent. Instead, an SPC only protects (to the extent that
the patent protected) the authorised uses of the active
ingredient(s) that are defined as the "product".

2.2 "Active" ingredients

As indicated above, SPCs are awarded in respect of a
"product", which is an active ingredient or a combination
of active ingredients. However, not all (combinations of) active
ingredients are eligible for SPC protection.

The first hurdle that must be overcome for the
"product" to be eligible for SPC protection is that it
must be defined only by reference to ingredients that are
"active" in the manner demanded by the provisions of
Article 1 of the relevant (medicinal or plant protection product)
SPC legislation.

3. The questions

Of course, in order to establish whether an ingredient is
"active", it is necessary to determine what is meant by
"active" in the context that it is used in Article 1 of
the SPC legislation./ page 2

This was an issue that was central to two of the cases recently
handled by the CJEU, namely:

C-11/13, Bayer Crop Science, where Advocate-General
Jääskinen has provided his (non-binding) opinion;
and

C-210/13, GSK Biologics, where the CJEU has issued a
judgement (by reasoned order).

The questions referred in the GSK Biologics case
related to the issue of whether a vaccine adjuvant per se
or in combination with an antigen, can qualify as an "active
ingredient" or "combination of active ingredients",
respectively, in the sense of Article 1 of Regulation 469/2009 (the
legislation governing SPCs for medicinal products).

On the other hand, the Bayer Crop Science case involved
questions relating to whether a safener qualified as an
"active substance" in the sense of Article 1 of
Regulation 1610/96 (the legislation governing SPCs for plant
protection products).

Although perhaps unfamiliar to those used to dealing with
medicinal products, a safener is a compound that is used to protect
a crop plant from the harmful effects of a herbicide that is
applied to the crop.

4. The CJEU's Response

4.1 GSK Biologics

The CJEU felt that an answer to the questions posed in GSK
Biologics could be gleaned from the Court's prior case
law. For this reason, the Court dispensed with the step of seeking
the opinion of an Advocate-General and instead issued a judgement
by reasoned order.

The prior case law relied upon by the CJEU was MIT
(C-431/04). In that case, it had been decided that:

"a substance which does not have any therapeutic effect
of its own and which is used to obtain a certain pharmaceutical
form of the medicinal product is not covered by the concept of
'active ingredient', which in turn is used to define the
term 'product'...

Therefore, the alliance of such a substance with a substance
which does have therapeutic effects of its own cannot give rise to
a 'combination of active ingredients' within the meaning of
Article 1(b)".

Having concluded that an adjuvant has no therapeutic effects on
its own, the Court then ruled that an adjuvant is not an
"active ingredient" within the meaning of Article 1(b)
(whether on its own or in combination with an antigen)

The Court felt that its conclusion on this point was further
supported by the rules that govern the submission of dossiers in
connection with the authorisation of vaccines, in which the Court
considered that distinctions were drawn between "active
ingredients" on the one hand and "adjuvants" on the
other.

4.2 Bayer Crop Science

Compared to the reasoning for the decision reached in GSK
Biologics, Advocate-General Jääskinen adopted a much
more inclusive approach when concluding that, in his opinion, a
safener can be an "active substance"./ page
3

Instead of asking whether the substance in question has any
"therapeutic" effect of its own, Advocate-General
Jääskinen adopted an approach that merely asks whether
that substance satisfies the provisions of Article 1(3) of
Regulation 1610/96 (the provision that defines "active
substances" in connection with plant protection products).

The principal reasons for the Advocate-General adopting such a
different approach are outlined in detail in the commentary
below.

5. Commentary

5.1 The differences

Although there are quite marked differences between the ruling
in GSK Biologics and the Advocate-General's opinion in
Bayer Crop Science, these are easily explained by the
differences in facts and the differences in the underlying law.

With regard to the facts, it is true to say that adjuvants and
safeners differ not only in their roles, but also in the effects
that are elicited by way of their administration. With respect to
the underlying law, however, there are even clearer differences
between the two cases.

In common with the predecessor legislation governing SPCs for
medicinal products (Regulation 1768/92), Regulation 469/2009 does
not define what is meant by "active ingredient". Thus,
the CJEU has been required to look elsewhere in order to interpret
that term. The interpretation that the CJEU settled upon was the
"usual meaning in everyday language", which they
believed excluded "substances forming part of a medicinal
product which do not have an effect of their own on the human or
animal body" (see paragraphs 17 and 18 of
MIT).

In stark contrast, Regulation 1610/96 does possess a specific
definition of "active substances" that the CJEU must take
into account. That definition encompasses substances that have a
specific or a general action, either on (parts of) plants
or against harmful organisms.

Moreover, although the current regulatory legislation for plant
protection products (Regulation 1107/2009) distinguishes between
safeners and other (active) substances, this was not the case for
the regulatory legislation (Directive 91/414) that was in place at
the time that Article 1 of Regulation 1610/96 came into force (or
even at the time that Bayer Crop Science obtained their MA).

This again contrasts to the situation in GSK Biologics,
where the relevant regulatory legislation (Directive 2001/83, which
was in place at the time that Regulation 469/2009 came into force
and when GSK Biologics obtained their MA) does appear to draw
distinctions between adjuvants on the one hand and "active
ingredients" on the other.

Thus, although the Advocate-General's opinion in Bayer
Crop Science is non-binding, the legal and factual differences
from the GSK Biologics case make it perfectly possible
(and perhaps even likely) that the CJEU will reach the same
conclusion as the Advocate-General. If this happens, the SPC regime
for plant protection products will effectively be confirmed as
being much more inclusive (in terms of the range of substances that
qualify for SPC protection) than the regime for medicinal product
SPCs.

5.2 Application to other cases

Although the innovative pharmaceutical industry will be
disappointed with the ruling in GSK Biologics, it may well
not mean the end of the road for those seeking SPC protection for
substances that arguably have no therapeutic activity of their
own./ page 4

One simple reason for this is that Article 1 of Regulation
469/2009 specifically mentions medicinal products (and the
"active ingredients" that those products contain) that
have a diagnostic purpose. There are many agents that are used for
diagnostic purposes and that have no therapeutic effect of their
own. Nevertheless, those agents are commonly treated under
regulatory legislation as "active" ingredients, and SPCs
are routinely granted to such agents.

Therefore, even with respect to SPCs for medicinal products, it
may still be possible to argue for the adoption of a more inclusive
approach to determining whether a particular substance is
"active" or not. However, such arguments will likely need
to focus upon proving that the ingredient in question is
"active" according to the common, everyday understanding
of the term "active ingredient".

Indeed, support for this more inclusive kind of approach may be
found in the Advocate-General's opinion in Bayer Crop
Science. For example, by pointing to case law of the CJEU
relating to whether an antiseptic could be regarded as exerting a
"pharmacological action" (C 308/11, Chemische Fabrik
Kreussler), the Advocate-General appears to imply that
substances exerting only an indirect pharmacological, immunological
or metabolic effect on a subject ought not to be excluded from the
definition of "active ingredients".

When the CJEU answers questions in the pending case C-631/13, it
may be that we will learn more about precisely where the dividing
line lies between the substances that qualify as "active
ingredients" and the substances that do not. This is because,
in that case, the CJEU has been asked questions that relate to a
substance (described as a carrier and an adjuvant) that is
covalently attached to an active ingredient, wherein the substance
in question has a therapeutic effect that is not described in the
relevant MA.

6. Practice Points

Substances that arguably do not have (direct) therapeutic
effects of their own may still be eligible for SPC protection,
depending upon the specific technical facts of each case.

For substances employed in plant protection products, there may
be more room for manoeuvre when arguing that the substance in
question is "active".

However, this is yet to be formally confirmed by the CJEU.

In any event, please contact us for advice if you have any
queries about the eligibility for SPC protection in respect of a
substance that is protected by a patent in which you have an
interest.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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